Phar 15.11(4)(4) Equipment used in compounding shall be thoroughly cleaned and sanitized after each use, and when necessary, prior to use, according to written policies and procedures, in order to reduce bioburden and reduce the opportunity for cross-contamination. Phar 15.11(5)(5) All equipment utilized in compounding preparations shall be inspected, maintained, calibrated, and validated at appropriate intervals, consistent with manufacturer’s recommendations, to ensure the accuracy and reliability of equipment performance. Records shall be kept indicating the equipment was inspected, maintained, calibrated, and validated. Phar 15.11 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18. Phar 15.12Phar 15.12 Records of compounding. The managing pharmacist shall ensure written or electronic compounding documentation to systematically trace, evaluate, and replicate the compounding steps throughout the process of a preparation. The compounding documentation shall be maintained for a period of 5 years after the date of the last refill. The compounding documentation shall include all of the following: Phar 15.12(1)(1) Official or assigned name, strength, and dosage form of the preparation. Phar 15.12(2)(2) List of all APIs and added substances and their quantities. Phar 15.12(3)(3) Vendor or manufacturer, lot number and expiration date of each APIs and added substances. Phar 15.12(4)(4) Equipment and supplies needed to prepare the preparation. Phar 15.12(5)(5) Mixing instructions pertinent to the replication of the preparation as compounded. Phar 15.12(6)(6) Compatibility and stability information, including references or laboratory testing. Phar 15.12(7)(7) Container or container-closure system used in dispensing. Phar 15.12(10)(10) Sterilization method when using non-sterile ingredients to make a sterile preparation. Phar 15.12(13)(13) Name of the person who performed the quality control procedures. Phar 15.12(19)(19) Documentation of any adverse reactions or preparation problems reported by the patient or caregiver. Phar 15.12 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18. Phar 15.13(1)(1) One or more pharmacists shall complete a verification of all the following before dispensing: Phar 15.13(1)(a)(a) Written procedures were followed in the compounding process.